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Completed

NCT Number: NCT00406536

Study of LYM-X-SORB™ to Improve Fatty Acid and Choline Status in Children With CF and PI

The purpose of this phase II research study is to evaluate the effectiveness of the next generation LYM-X-SORB™ in improving the essential fatty acid (EFA) and choline status for children and adolescents with Cystic Fibrosis (CF) and pancreatic insufficiency (PI).

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Exocrine Pancreatic Insufficiency Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Pancreatic Insufficiency Respiratory Tract Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, 19104, United States

About this study

Fat malabsorption is common in individuals with cystic fibrosis (CF) and pancreatic insufficiency (PI). This places them at risk for caloric, essential fatty acid, and choline deficiency, which may in turn, lead to growth failure and a poorer clinical course. The purpose of this research study is to find whether or not taking LYM-X-SORB™ over an 18-month period, every day, will correct the problem people with CF and PI have with absorbing fat and choline. Participation will help CF doctors and other healthcare professionals learn more about the potential benefits of LYM-X-SORB™ to children and adolescents with CF and PI. These benefits may include better absorption of fat, better choline status, better growth in height, weight, muscle and bone, better lungs, and improvement of health status.

The study will enroll a total of 78 participants from Children's Hospital of Philadelphia (CHOP) and from several other Cystic Fibrosis Centers. One half of the participants will be randomly picked to receive the active powder with the LYM-X-SORB™ supplement and one half will receive a placebo (with no active supplement).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed as having cystic fibrosis (CF) with pancreatic insufficiency (PI)
  • Subjects aged 6 to 17 years of age
  • In usual state of good health
  • Family and subject commitment to the 18-month study protocol
  • Fecal elastase < 15µg/g stool

Exclusion criteria

  • Forced expiratory volume at one second, % predicted (FEV1) < 40% predicted
  • Other chronic health conditions that may affect GI absorption, growth, dietary intake, nutritional status
  • Liver disease, lung transplant, celiac disease, allergy/intolerance to wheat/gluten, pregnant
  • Participation in another CF nutrition-related intervention study
  • Regular intake of fatty acids (i.e., fish oils) or choline nutritional supplements
  • Home parenteral lipid administration (i.e., intralipids)

Treatment and study plan

Lym-X-Sorb powder

Dietary Supplement

Lym-X-Sorb is an organized matrix of lyso phosphatidylcholine (LPC), free fatty acid (FFA) and monoglyceride formulated at 20wt% with flour and sugar. A dosage contains 32 grams of powder and is consumed with food twice a day (6 to 11.9 years old) or three times per day (12 to 17.9 years old) for 18 months.

Placebo Powder

Dietary Supplement

The placebo is composed of soybean oil, sunflower oil, fully hydrogenated cottonseed oil and flax seed oil dispersed at 16wt% on flour and sugar. The placebo is >99% triglycerides with no trans fatty acids. The fatty acid composition and caloric content is designed to match the active supplement (Lym-X-Sorb). A dosage contains 32 grams of powder and is consumed with food twice a day (6 to 11.9 years old) or three times per day (12 to 17.9 years old) for 18 months.

Primary outcomes

  1. Improvements in essential fatty acid (EFA) and choline status over a 12-month period.

    Time frame: 12-month period

Secondary outcomes

  1. Improvements in growth, nutritional, and pulmonary status over an 18-month period.

    Time frame: 18-month period

Sponsors and collaborators

Lead sponsor

Avanti Polar Lipids, Inc.

Industry

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Phase II Study: LYM-X-SORB™, an Organized Lipid Matrix: Fatty Acids and Choline in CF

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Dec 4, 2006
Registry last updated
Jan 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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